Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: exercise

• Registration Number: NCT01053091
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The purpose of this study is to investigate how exercise-base rehabilitation influences circulatory functions in patients with diastolic heart failure (DHF).

Detailed Description

A quasi-experimental design will be used in this investigation. Eighty DHF patients will be recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided informed consent. These subjects will be randomized into the trained (n=40) and the control groups (n=40). The trained subjects will be trained on a bicycle ergometer at about 60-70%of heart rate reserve for 35-55 minutes (that will include 10-min warm-up, 15-35-min main exercise, and 10-min cool-down) per day, 3 days per week for 12 weeks. The control subjects will maintain their normal living pattern. Subjects' physical fitness, oxygen transport and utilization of exercising skeletal muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions will be measured at pre-training stage and following the 8th and 12th week of the training program. Experimental results were analyzed by descriptive statistics (percentage, mean, and standard deviation), independent t-test, two-way ANOVA, and two-way ANCOVA. Previous researches were mainly focus on systolic heart failure, less on diastolic heart failure. We study the above parameter to realize the physiological response to exercise of these patients and discover the appropriate exercise intensity for prescription.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2011-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• cardiac event with optimal medial treatment within 3 months and have 4 more weeks spared from heart disease attack or major cardiac procedure.
• LVEF>50%

Exclusion Criteria

• unstable angina pectoris,
• uncompensated heart failure,
• myocardial infarction during the past 4 weeks,
• complex ventricular arrhythmias,
• orthopedic or neurological limitations to exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	exercise	exercise

Primary Outcome Measures

Name	Time	Method
physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics	one year

Secondary Outcome Measures

Name	Time	Method
blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions change between pre-ex and post-ex.	one year

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital; 🇨🇳 Keelung, Taiwan